Are international patent applications required to incorporate “Sequence Listings” by reference?

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

No, international patent applications during the international stage are exempt from the requirement to incorporate “Sequence Listings” by reference. This exemption is specifically stated in 37 CFR 1.823(b)(2):

“37 CFR 1.823(b)(2) specifically exempts international applications during the international stage from the incorporation by reference requirement in 37 CFR 1.823(b)(1).“

This means that while domestic U.S. patent applications and national stage applications of international applications must include an express incorporation by reference of the “Sequence Listing” in the specification, international applications in the international phase do not need to meet this requirement.